Bay­er wins pri­or­i­ty re­view for CKD pro­gram finerenone af­ter PhI­II da­ta showed a de­lay in dis­ease pro­gres­sion

Less than three months af­ter Bay­er re­leased pos­i­tive Phase III da­ta for a top pro­gram, the FDA has agreed to take up its case.

Reg­u­la­tors have grant­ed pri­or­i­ty re­view for finerenone, an ex­per­i­men­tal drug in pa­tients with chron­ic kid­ney dis­ease and type 2 di­a­betes, Bay­er an­nounced Tues­day. Bay­er did not un­veil an ex­pect­ed PDU­FA date but not­ed the FDA would like­ly give finerenone a typ­i­cal six-month look-over.

“Based on study da­ta, finerenone of­fers a po­ten­tial new strat­e­gy to de­lay CKD pro­gres­sion, while re­duc­ing the risk of car­dio­vas­cu­lar events,” Bay­er CMO Michael De­voy said in a state­ment. “We’re en­cour­aged that the FDA has grant­ed the NDA a pri­or­i­ty re­view.”

The de­ci­sion comes fol­low­ing the pro­gram’s Phase III tri­al in which it showed a sta­tis­ti­cal­ly sig­nif­i­cant de­lay in CKD, for both the dis­ease it­self and CKD re­lat­ed to type 2 di­a­betes. Look­ing for a sus­tained de­crease of es­ti­mat­ed glomeru­lar fil­tra­tion rate greater than or equal to 40% from base­line, or re­nal death, finerenone cut risk by 18% over a pe­ri­od of at least four weeks.

That amount­ed to a sparkling p-val­ue of p=0.0014. Bay­er al­so fol­lowed up on pa­tients for a me­di­an of 2.6 years as finerenone was added to the high­est-tol­er­at­ed dose of stan­dard treat­ment.

Bay­er al­so hit on an im­por­tant sec­ondary end­point, de­spite com­ing clos­er to miss­ing than the pri­ma­ry. Finerenone re­duced the risk by 14% in time to car­dio­vas­cu­lar death, non-fa­tal my­ocar­dial in­farc­tion, non-fa­tal stroke or hos­pi­tal­iza­tion for heart fail­ure com­pared to place­bo, amount­ing to a p-val­ue of p=0.03391.

The can­di­date is a non-steroidal min­er­alo­cor­ti­coid re­cep­tor in­hibitor, look­ing to tamp down on what re­searchers found is a trig­ger for both in­flam­ma­tion and fi­bro­sis. Bay­er the­o­rized finerenone could pro­vide more ben­e­fit in stop­ping fi­bro­sis while lim­it­ing in­flam­ma­tion in the heart and kid­neys.

Though there are quite a few CKD drugs out there, CKD pa­tients of­ten ex­pe­ri­ence mul­ti­ple drug fail­ures due to ad­verse events, In­di­ana Uni­ver­si­ty School of Med­i­cine pro­fes­sor Ra­jiv Agar­w­al told End­points News in Oc­to­ber. While finerenone has a short­er half-life than most, al­low­ing it to be ex­punged from the body more quick­ly, the pro­gram saw a high­er rate of events re­lat­ed to high potas­si­um lev­els, af­fect­ing 18% of the drug arm com­pared to half that in the con­trol.

An ap­proval would mark a win for the Ger­man phar­ma af­ter a few tu­mul­tuous years in R&D. Bay­er cut 900 R&D jobs back in No­vem­ber 2018 as part of a broad­er re­struc­tur­ing plan in the wake of its ac­qui­si­tion of Mon­san­to, but more re­cent­ly has be­gun a push in­to gene and cell ther­a­pies. The phar­ma bought out AskBio for $4 bil­lion in Oc­to­ber and, in De­cem­ber, es­tab­lished a cell and gene ther­a­py plat­form with­in its phar­ma­ceu­ti­cals di­vi­sion in or­der to con­sol­i­date all of its re­lat­ed projects un­der one um­brel­la.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Deval Patrick (Mary Altaffer/AP Images)

De­val Patrick joins Cerev­el board, fur­ther in­ter­twin­ing com­pa­ny with Bain Cap­i­tal

Tony Coles’ team at Cerevel Therapeutics is adding two high-profile board members, including an ex-governor that has lots of connections to the Boston area where the biotech is based.

Former Massachusetts Gov. Deval Patrick is hopping on Cerevel’s board of directors, the company announced Thursday, joining less than three months after Cerevel went public on the backs of Perceptive’s ARYA II SPAC. And in a twist, Pfizer’s new business development chief Deborah Baron is joining the board as well, about three years after the Big Pharma shuttered the neuroscience pipeline that Cerevel is seeking to revive.

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Northway Biotech's new manufacturing facility in Greater Boston

North­way Biotech sets up shop in Boston hub, look­ing to court more cus­tomers with bi­o­log­ics-fo­cused plant

Getting a foot in the door in Boston’s bustling biopharma hub is a rite of passage for many companies, but it comes with a steep price tag. Lithuanian CDMO Northway — now with a new moniker — will set up a new plant in close proximity, and it’s hoping its biologics focus will find a willing customer base.

Northway Biotech (formerly Northway Biotechpharma) on Wednesday held a virtual grand opening ceremony for its $40 million Waltham, MA facility — a 30,000 square-foot cGMP manufacturing and process development plant that will widely expand on the company’s previous capabilities.

News brief­ing: Five pub­lic biotechs, over 2 days, raise $883M from fresh of­fer­ings; Bel­gian biotech ex­pands Se­ries B fund­ing

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.